Last reviewed · How we verify
EU-approved Keytruda
Keytruda is a monoclonal antibody that blocks PD-1 on immune cells, allowing the immune system to recognize and attack cancer cells.
Keytruda is a monoclonal antibody that blocks PD-1 on immune cells, allowing the immune system to recognize and attack cancer cells. Used for Metastatic melanoma, Non-small cell lung cancer (NSCLC), Head and neck squamous cell carcinoma.
At a glance
| Generic name | EU-approved Keytruda |
|---|---|
| Sponsor | Celltrion |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Keytruda (pembrolizumab) binds to programmed death receptor 1 (PD-1) on T cells, preventing interaction with its ligands PD-L1 and PD-L2 expressed on tumor cells and immune cells. This blockade releases the 'brakes' on the immune system, restoring T cell proliferation, activation, and anti-tumor function. By reinvigorating exhausted T cells, pembrolizumab enables durable anti-tumor immunity across multiple cancer types.
Approved indications
- Metastatic melanoma
- Non-small cell lung cancer (NSCLC)
- Head and neck squamous cell carcinoma
- Hodgkin lymphoma
- Urothelial carcinoma
- Gastric cancer
- Cervical cancer
- Renal cell carcinoma
- Colorectal cancer (microsatellite instability-high or mismatch repair deficient)
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Decreased appetite
- Immune-mediated pneumonitis
- Immune-mediated hepatitis
- Immune-mediated colitis
- Immune-mediated thyroiditis
- Rash
- Pruritus
Key clinical trials
- A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer (PHASE3)
- A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- EU-approved Keytruda CI brief — competitive landscape report
- EU-approved Keytruda updates RSS · CI watch RSS
- Celltrion portfolio CI